[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (incomplete documentation, 20 h occlusive treatment, 2 animals, 72 h scoring not performed)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive treatment, 20h treatment duration, 72 h scoring not performed, 2 animals)

Principles of method if other than guideline:

BASF-test:
The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. Additionally, the substance was applied for 1, 5 and 15 minutes. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours, 5, 7 and 8 days after administration. Findings were graded as described in OECD test guideline 404.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper

EC Number:

249-125-4

EC Name:

[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper

Cas Number:

28654-73-1

Molecular formula:

C47 H49 Cu N11

IUPAC Name:

Copper,[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyanine-C,C,C-trimethanaminato(2-)-κN29,κN30,κN31,κN32]-

Details on test material:

Please refer to confidential details on test material

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.75 kg (male) and 3.41 kg (female)

ENVIRONMENTAL CONDITIONS: not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Concentration: 80% (in water)

Duration of treatment / exposure:

20 h

Observation period:

7 days

Number of animals:

2 rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: with water (possibly containing mild detergent)
- Time after start of exposure: 20 h

SCORING SYSTEM: as described in OECD guideline 404 (the BASF-code from the raw data was converted into the Draize scheme.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 - 48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 - 48 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

(2 animals)

Time point:

other: all timepoints

Score:

0

Max. score:

4

Reversibility:

other: no effects

Other effects:

Substance residues (light-blue) were noted in both animals at 24 h and 48 h after exposure and in animal 2 until day 6.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information